MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 STR INSRTR THREADED SHAFT; INSTRUMENT, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during an initial hip arthroplasty, the impactor end broke while surgeon was impacting the cup.No adverse event noted to patient.Additional information has been requested; however, none is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Udi: (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual examination identified that the shaft had fractured at the threaded portion and the fractured piece was not returned.Sem analysis determined that the material was conforming to specification material was conforming to specifications and a fracture analysis confirmed that the fracture is due to bending overload.Device history record (dhr) was reviewed and no discrepancies were found.The reported fracture is most likely due to bending overload; however, the root cause of the overload is unknown.A change notice and change order were done previously to change the heat treat condition to decrease the brittleness of threads.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: G7 STR INSRTR THREADED SHAFT
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8133258
• MDR Text Key: 129470809
• Report Number: 0001825034-2018-10762
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110003452
• Device Lot Number: 421222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 01/23/2019; 07/15/2019
• Supplement Dates FDA Received: 01/24/2019; 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1